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临床试验/NCT02407717
NCT02407717已完成不适用

Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

G. d'Annunzio University1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
330
试验地点
1
主要终点
Major bleeding and clinically relevant non major bleeding

研究概览

简要总结

Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.

Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.

The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.

Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients with cancer hospitalized for an acute medical illness

排除标准

  • current use of oral or parenteral anticoagulant treatment
  • no informed consent to participate

结局指标

主要结局

Major bleeding and clinically relevant non major bleeding

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week

次要结局

  • Minor bleeding(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
  • Venous thromboembolism(Participants will be followed up to 3 months after discharge, an expected average of 13 weeks)

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcello Di Nisio

Principal Investigator

G. d'Annunzio University

研究点 (1)

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